Clinical Project Manager
Wellstat Therapeutics Corporation, a development-stage pharmaceutical company located in Rockville, MD, currently has an opening for a Clinical Project Manager (CPM). This position reports to the Director, Clinical Projects.
Wellstat Therapeutics is part of the Wellstat group of companies which is dedicated to the discovery, development and commercialization of treatments for patients in the fields of oncology, metabolic, neurometabolic and neurodegenerative diseases; biological agents that meet the challenges of cancer; and therapies for major sight-threatening diseases.
The CPM is responsible for helping to plan, execute, and manage the overall day-to-day clinical operations for his/her assigned clinical trials. This position will work directly with the Director, Clinical Projects to ensure studies are proceeding according to expectations (e.g., on time and on budget). This position requires knowledge of FDA Regulations, ICH GCPs, and adherence to internal SOPs. This position may manage external vendors and interact directly with clinical sites; therefore, good communication skills are essential.
- Provide clinical operational expertise to deliver clinical trial deliverables
- Review and provide input on various study documents (e.g., Protocols, Investigator Brochures, Statistical Analysis Plans, TLF Shells, Informed Consent Forms, etc.)
- Participate in selection of external vendors for outsourced clinical trials (e.g., CROs, central IRBs, central labs), including input on developing RFPs
- Manage external vendors
- Manage study budget
- Participate in site selection for clinical trials, including review and approval of sites selected by CROs
- May manage both internal and external CRAs
- Assist in planning and presenting at Investigator’s Meetings
- Ensure essential study documents obtained from clinical sites are complete and accurate
- May oversee submission of study documents to central IRB
- Manage assigned studies and ensures studies are meeting deliverables (e.g., timelines, budgets)
- Ensure final deliverables (study documents, data, CSRs) are accurate and meet quality expectations
- Review draft tables, listings, and figures to ensure data are consistent and accurate
- Provide input into final CSR
- 5-8 years’ experience in the pharmaceutical or biotechnology industry, with at least 1-2 years as a Project Manager
- Experience managing Phase I-III clinical trials
- Experience managing external vendors
- Excellent written and communication skills
- Willingness to travel (~10%)
- Knowledge of FDA, ICH, and GCP regulations
- Experience managing pediatric trials or clinical trials in rare diseases, a plus
Bachelor’s Degree in scientific discipline or equivalent
During the COVID-19 pandemic, it is expected that the successful candidate will work onsite in Rockville, MD at least two days per week. Thereafter, the onsite work schedule is yet to be determined.
Wellstat Therapeutics Corporation is an equal opportunity employer and offers an excellent salary and benefits package.